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Electronic Validation Consultant

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

VALGENESIS CONSULTANT

(DIGITAL GxP LABORATORY INFORMATICS SYSTEMS)

SUummary

The ideal candidate has ValGenesis paperless validation experience and can act as the subject matter expert (SME) for the software.

  • Drive roll out of software and processes.
  • Migrate existing documentation.
  • Perform risk assessments.
  • Build out approval functionality.

On-going support to team by routing documents for review/approval, executing documents, and creating traceability. The Paperless Validation Consultant will provide support in a cGMP biopharma manufacturing environment. Provide qualification and validation leadership for all digital technologies surrounding eVLM.

As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the eVLM CSV Lead will be involved in computer systems validation for paperless validation. Will be instrumental in developing and managing GxP lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. 

Requirements

  • Computer System Validation (CSV) experience within the life sciences industry, including validation of eVLM, paperless validation systems, such as ValGenesis, HP ALM, Kneat, Adventsys, or Veeva.
  • Experience collaborating with stakeholders and driving the deliverables of others.
  • Experience creating validation master plans and performing risk assessments.
  • Direct experience developing validation protocols and execution of protocols.
  • Knowledge of current industry standards such as GAMP5 and ASTM E2500.
  • Passionate about leading and mentoring others.
  • Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
  • Excellent client communication skills.

This is a challenging and rewarding opportunity to join a dynamic team and contribute to the success of a high-profile project. If you are a self-motivated individual with a passion for ValGenesis and a proven track record of success in regulated industries, we encourage you to apply.

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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